NCT03064165

Brief Summary

The study investigates the effect of an obturator nerve block on the postoperative pain and opioid consumption after total hip replacement.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Aug 2017

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 13, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 24, 2017

Completed
6 months until next milestone

Study Start

First participant enrolled

August 15, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2018

Completed
Last Updated

September 10, 2018

Status Verified

September 1, 2018

Enrollment Period

10 months

First QC Date

February 13, 2017

Last Update Submit

September 7, 2018

Conditions

Obturator Nerve BlockTotal Hip Replacement

Outcome Measures

Primary Outcomes (1)

  • Opioid dose 0-12 hour after total hip replacement

    Cumulated dose of opioid 0-12 hour after total hip replacement

    0-12 hour after completion of total hip replacement

Secondary Outcomes (15)

  • Cumulated dose of opioid 12-18 hours after total hip replacement.

    12-18 hours after completion of total hip replacement

  • Pain at rest at time of examination (numeric rating scale)

    1, 2, 5, 7 and 24 hours after completion of total hip replacement

  • Pain at passive 90-degree hip flexion (numeric rating scale)

    1, 2, 5, 7 and 24 hours after completion of total hip replacement

  • Worst pain during ambulation on the day of surgery

    5 hours after completion of total hip replacement

  • Time from completion of surgery to first dose of opioid

    24 hours after completion of total hip replacement

  • +10 more secondary outcomes

Study Arms (2)

Obturator nerve block

EXPERIMENTAL

Postoperative obturator nerve block with 15 mL bupivacain 5 mg/mL and epinephrine 5 µg/mL.

Drug: Bupivacaine-epinephrineProcedure: Obturator nerve block

Sham block

PLACEBO COMPARATOR

Postoperative sham-block with normal saline.

Procedure: Sham blockDrug: Sodium Chloride 9mg/mL

Interventions

Bupivacaine-epinephrineDRUG

Nerve block with 15 mL bupivacain 5 mg/mL with epinephrine 5 µg/mL.

Obturator nerve block
Sham blockPROCEDURE

Injection as for obturator nerve block, but with placebo

Sham block
Obturator nerve blockPROCEDURE

Postoperative obturator nerve block

Obturator nerve block
Sodium Chloride 9mg/mLDRUG

Placebo

Sham block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients for primary hip replacement in spinal anesthesia
  • Age \>= 18 years
  • American Society of Anesthesiologists physical status classification score I-III
  • Informed consent

You may not qualify if:

  • Lacking the ability to corporate
  • Lacking the ability to speak danish
  • Planned discharge on the same day of surgery
  • Neuropathy of the lower extremities
  • Contraindications for NonSteroidal Anti-Inflammatory Drugs (NSAID)
  • Contraindications for dexamethasone
  • Chronic opioid demanding pain
  • Pregnancy
  • Allergy towards one or both investigatory medicinal products
  • Active treatment with amiodarone
  • Active treatment with verapamil
  • Active treatment with corticosteroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Elective Surgery Centre

Silkeborg, DK-8600, Denmark

Location

Related Publications (1)

  • Nielsen ND, Runge C, Clemmesen L, Borglum J, Mikkelsen LR, Larsen JR, Nielsen TD, Soballe K, Bendtsen TF. An Obturator Nerve Block does not Alleviate Postoperative Pain after Total Hip Arthroplasty: a Randomized Clinical Trial. Reg Anesth Pain Med. 2019 Jan 23:rapm-2018-100104. doi: 10.1136/rapm-2018-100104. Online ahead of print.

    PMID: 30679337DERIVED

MeSH Terms

Interventions

Sodium Chloride

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD-fellow

Study Record Dates

First Submitted

February 13, 2017

First Posted

February 24, 2017

Study Start

August 15, 2017

Primary Completion

June 8, 2018

Study Completion

June 8, 2018

Last Updated

September 10, 2018

Record last verified: 2018-09

Locations

DK(1)